NCT01164202

Chemoembolization of the Liver With or Without Sunitinib Malate in Treating Patients With Liver Cancer

A Double-Blind, Randomized, Phase II/III Study Comparing the Use of Chemoembolization Combined With Sunitinib Against Chemoembolization Combined With a Placebo in Patients With Hepatocellular Carcinoma (SATURNE)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Federation Francophone de Cancerologie Digestive · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping anticancer drugs near the tumor. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether chemoembolization is more effective with or without sunitinib malate in treating patients with liver cancer. PURPOSE: This randomized phase II/III trial is studying the side effects of chemoembolization of the liver and to see how well in works when given together with or without sunitinib malate in treating patients with liver cancer.

Detailed description

OBJECTIVES: Primary * To evaluate unacceptable bleeding or hepatic failure at 10 weeks post-treatment in patients with unresectable hepatocellular carcinoma treated with transarterial chemoembolization in combination with sunitinib malate versus transarterial chemoembolization alone. * To evaluate the overall survival of these patients. Secondary * To evaluate the tumor stabilization rate in these patients. * To evaluate the safety of this regimen in these patients. * To evaluate the disease-free survival of these patients. * To evaluate the relapse-free survival of these patients. * To evaluate the quality of life of these patients. * To evaluate the overall survival rate at 2 years of these patients. OUTLINE: This is a multicenter study. Pilot: Patients receive oral sunitinib malate once daily on days 1-28. Beginning 7-10 days later, patients undergo 1-3 courses of transarterial chemoembolization (TACE). Treatment repeats every 6 weeks for 1 year. Randomization: Patients are stratified according to main tumor diameter (\< 5 cm vs ≥ 5 cm), nodular involvement (uninodular vs multinodular), and center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive sunitinib malate and TACE as in the pilot phase. * Arm II: Patients receive oral placebo once daily on days 1-28 and TACE as in the pilot phase. Quality of life is assessed periodically.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate	placebo 3cps/days 4 weeks over 6 during 1 year
DRUG	Placebo	placebo 3cps/days 4 weeks over 6 during 1 year
PROCEDURE	transarterial chemoembolization	Chimioembolisation

Timeline

• Start date: 2010-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2010-07-16
• Last updated: 2022-03-18
• Results posted: 2022-03-18

Locations

31 sites across 1 country: France